Category Archives: Sunshine Biopharma Inc. SBFM

The stock is holding a support level at 50 cents. A thinly traded stock with a low float, SBFM can move rapidly in either direction. Technical traders will be watching for volume to accompany buying pressure to see if a test of resistance at 75 cents is in the future for this junior biotech.

It’s easy to forget that, in spite of periodic frustrations and disappointments, very real progress has been and continues to be made in the war against cancer. Decades of research have given us a much better understanding of how cancer operates at the cellular level. Developments in cancer prevention, screening, and therapy have saved millions of lives. Although there are still 1.5 million new cases of cancer diagnosed in the U.S. every year, the country now also has at least 11 million survivors of various types of cancer. But it’s important to remember that virtually all types of cancer are either aggressive at the onset, or eventually become aggressive.

In the case of breast cancer, there are now 2.5 million Americans who are living with the disease, with 230,000 new cases detected annually. There are two genes which have been associated with aggressive breast cancer: Her2 and Top2. Even though Herceptin, a $1.8 billion drug marketed by Roche, is an effective treatment for Her2, there are currently no approved therapies that target Top2. The Top2 gene encodes Topoisomerase II, an enzyme that unwinds DNA and is required for cell proliferation. Overexpression of Topoisomerase II allows the cell to divide more rapidly and as a result become more aggressive. It has been associated with breast, prostate, colon, lung, and other deadly cancers. Inhibition of Top2 activity is critical to treat multi-drug resistant breast cancer and other types of aggressive cancer, such as small-cell lung cancer.

Adva-27a, lead compound of Sunshine Biopharma, if approved, will be the only Topoisomerase II inhibitor on the market. Shown to be 16 times more effective at killing multi-drug resistant breast cancer cells than Etoposide, the most commonly used drug, Adva-27a can be used to treat other Top2 positive cancer types, such as lung, prostate, colon, stomach, and ovarian cancer. As the only Top2 inhibitor, and since it could help terminally ill patients, Adva-27a is likely to be granted fast-track designation.

For additional information, visit the company’s websites at www.SunshineBiopharma.com

When Sunshine Biopharma, a development stage pharmaceutical company focused on cancer treatments, recently announced successful test results for its lead compound, Adva-27a, it represented one of several important milestones being met on the drug’s anticipated fast-track path to approval as a vital weapon in fighting particular forms of aggressive cancers.

The latest study measured the ability of Adva-27a to inhibit the activity of Topoisomerase II (Top2) cancer growth enzyme, and results showed that the new drug is an excellent inhibitor, requiring a concentration of only 13.7 micromolar Adva-27a to inhibit 50% of the enzyme’s activity. Topoisomerase II is overproduced in aggressive cancer cells, giving them the ability to grow rapidly, and has been implicated in breast, prostate, colon, lung, stomach, and ovarian cancer.

The success of Adva-27a is especially important, since there are currently very limited options for Top2 positive patients. With no other effective therapy for Top2, Adva-27a is likely to be granted fast-track designation, especially since it could help terminally ill patients, further enhancing the drug’s unique potential in the marketplace:

• Adva-27a will be the only Topoisomerase II inhibitor on the market
• Adva-27a can be taken orally.
• Adva-27a is unaffected by P-Glycoprotein, the enzyme responsible for making cancer cells resistant to anti-tumor drugs.
• Adva-27a has an excellent clearance time, reducing toxicity risks, and clearance is independent of Cytochrome P450, making it less likely to produce toxic intermediates.
• Adva-27a’s initial indication will be multi-drug resistant breast cancer.
• Adva-27a has been shown to be 16 times more effective at killing multi-drug resistant breast cancer cells than Etoposide, the most commonly used drug.
• Adva-27a can be used to treat other Top2 Positive Cancer Types (Prostate, Colon, Lung, Stomach, Ovarian).

Sunshine Biopharma is planning to expand its product line through acquisitions and/or in-licensing, as well as in-house research and development.

For additional information, visit the company’s websites at www.SunshineBiopharma.com

A drug which could fill a major gap in the treatment of aggressive cancers has been developed by Sunshine Biopharma, a development stage pharmaceutical company focused on drugs for the treatment of various forms of cancer.

The company’s lead compound, Adva-27a, has been shown to be remarkably effective in dealing with the Topoisomerase II (Top2) gene, which is responsible for the production of Top2, associated with breast, prostate, colon, lung, stomach, and ovarian cancer. Aggressive cancer cells produce too much Top2, and there are currently no satisfactory therapies for Top2 positive patients. The demonstrated effectiveness of Sunshine’s Adva-27a is seen as a breakthrough. Adva-27a is, for example, 16 times more effective at killing multi-drug resistant breast cancer cells than Etoposide, the most commonly used drug.

In the case of breast cancer, although progress continues to be made, there are 230,000 new cases each year in the U.S. alone, with 2.5 million American women currently living with the disease. There are two genes associated with aggressive forms of breast cancer, Her2 and Top2. Herceptin, a drug marketed by Roche, is effective for Her2 positive patients, driving sales of roughly $1.8 billion annually. With no effective therapy for Top2, Adva-27a is likely to be granted fast-track designation, especially since it could help terminally ill patients. The drug has been undergoing pre-clinical trials, with very positive results.

In addition, the Adva-27a can be used to treat other Top2 positive cancer types, including lung, colon, prostate, and other common forms of cancer. The drug is unaffected by P-Glycoprotein, the enzyme responsible for making cancer cells resistant to anti-tumor drugs. It also has an excellent clearance time, reducing toxicity risks, and clearance is independent of Cytochrome P450, a mechanism that is less likely to produce toxic intermediates.

For additional information, visit the company’s websites at www.SunshineBiopharma.com

Sunshine Biopharma, Inc. is focused on the research, development and commercialization of drugs designed to treat various forms of cancer. The Company’s lead compound, Adva-27a, is a multi-purpose anti-tumor compound currently in preclinical stage with plans to conduct Phase I clinical trials at the Segal Cancer Centre of the Jewish General Hospital, one of McGill University’s Hospital Centers located in Montreal, Canada.

Almost 1.5 million new cases of cancer are diagnosed in the U.S. each year, according to the American Cancer Society. Virtually all cancer types are either aggressive at the onset or become aggressive over time. There are two genes associated with aggressive forms of cancer: Her2 and Top2. Herceptin®, a drug marketed by Roche, is an effective treatment for Her2 positive patients, but there are currently no effective therapies that target Top2 positive patients. Management of Topoisomerase II (Top2) activity is vital in the fight against aggressive types of cancer, including multi-resistant breast cancer and metastatic cancer.

Adva-27a is a Carbon-Difluoride derivative of Etoposide, which has been on the market for more than twenty years under various brand names. Although Etoposide has enjoyed great success, it suffers from molecular instability leading to reduced efficacy and high toxicity. Using its Carbon-Difluoride platform technology, Advanomics constructed a derivative of Etoposide that is up to 16-times more effective at killing multi-drug resistant breast cancer cells than the existing Etoposide molecule. This new compound can be taken orally, and if FDA approved, will be the only Top2 Inhibitor on the market.

The U.S. Food and Drug Administration’s (FDA) approval process is likely to be granted fast-track designation since Adva-27a has the potential to help terminally ill patients with no other therapy options and can be used to treat multiple cancer types. As a result of its unique capabilities, versatility and lack of competition, Sunshine Biopharma’s lead compound could significantly exceed the typical revenues generated from anti-cancer drugs, which in general reach $1 billion in annual sales within two or three years of FDA approval.

Sunshine Biopharma Inc., a development stage pharmaceutical company focused on the treatment of various forms of cancer, announced earlier today that it has completed a study in which the ability of Adva-27a, its lead compound, to inhibit the activity of Topoisomerase II was directly measured.

Topoisomerase II (Top2) is an enzyme that enables cancers to grow rapidly. In multi-drug resistant breast cancer, the gene that encodes Top2 has been found to be amplified as much as 1,000%, allowing these cancer cells to make tens of thousands of Top2 molecules. By inhibiting Topoisomerase II activity, Adva-27a would arrest the ability of cancer cells to multiply rapidly and spread to other parts of the body.

The ability of Adva-27a to inhibit Topoisomerase II was measured in a concentration dependent fashion using highly purified, human Topoisomerase II alpha and concatenated plasmid DNA as a substrate. According to today’s press release, Adva-27a was shown to be an excellent inhibitor of Top2 in the study. Inhibition of 50% of Top2 activity (IC50) took place at a concentration of only 13.7 micromolar Adva-27a.

Dr. Steve N. Slilaty, Sunshine’s President and CEO, stated, “An IC50 of 13.7 micromolar indicates that Adva-27a is an excellent inhibitor of Topoisomerase II. Compounds displaying IC50’s in the 75 to 100 micromolar range cannot be developed into effective drugs as the amounts which would have to be administered to patients would be too toxic. We are delighted to find that our compound has such low IC50. This is a significant milestone in our continued development of Adva-27a.”